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A kind of esomeprazole magnesium intestinal capsule and preparation method thereof

A technology of esomeprazole magnesium enteric coating and esomeprazole magnesium, which is applied in the field of esomeprazole magnesium enteric coating capsule and its preparation, can solve the problems of drug oxidative degradation, etc., to prevent oxidative degradation, facilitate Marketing and clinical use, the effect of preventing decomposition

Active Publication Date: 2018-03-06
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese invention patent CN102670521A discloses a kind of esomeprazole magnesium enteric-coated pellets and its preparation method. The enteric-coated pellets use acid-base regulators in the drug-containing layer and the isolation layer to adjust the pH value and enhance the esomeprazole magnesium enteric-coated pellets. The stability of meprazole magnesium, but no antioxidant is added in the drug layer, the drug is easy to cause oxidative degradation during preparation and storage

Method used

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  • A kind of esomeprazole magnesium intestinal capsule and preparation method thereof
  • A kind of esomeprazole magnesium intestinal capsule and preparation method thereof
  • A kind of esomeprazole magnesium intestinal capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 The preparation of esomeprazole magnesium enteric-coated pellets

[0024] (1) Preparation of blank pellet cores

[0025] Starch 400g

[0026] Sucrose 477g

[0027] Sodium hydroxide 30g

[0028] Syrup (60%) 200g

[0029] It is prepared with production equipment such as centrifugal granulator, extrusion extrusion spheronizer, high-efficiency coating machine and fluidized bed coating granulator. The prepared blank pellet cores are screened, and pellets with a particle diameter of 0.4-0.6 mm are selected for drug packaging.

[0030] (2) Preparation of the drug-loaded layer

[0031] Esomeprazole Magnesium 1000g

[0032] Microcrystalline Cellulose 300g

[0033] Sodium hydroxide 50g

[0034] Polysorbate 80 10g

[0035] Hydroxypropyl Methyl Cellulose 150g

[0036] Water 10000g

[0037]Pass esomeprazole magnesium through a 200-mesh sieve for later use, dissolve sodium hydroxide in about 2kg of water, disperse the hypromellose with hot water, add the remainin...

example 1

[0083]Experiments were carried out on the influencing factors of high temperature (temperature 60°C±2°C), high humidity (RH75%, RH92.5%) and light (illuminance 4500±500LX).

[0084] Influencing factor test results

[0085]

example 2

[0087] Take the example sample and carry out acceleration (at a temperature of 40°C±2°C and a relative humidity of 75%±5%) for 6 months and a long-term period (at a temperature of 25°C±2°C and a relative humidity of 60%±5%) according to the package on the market. 10% condition) 6-month pilot study.

[0088] Accelerated test (temperature 40℃±2℃, relative humidity 75%±5%) 6-month test results

[0089]

[0090] Long-term (temperature 25 ℃ ± 2 ℃, relative humidity 60% ± 10%) test results for 6 months

[0091]

[0092] According to the experimental data, according to the results of the test and investigation of the influencing factors of this product, the appearance of the sample has not changed, and the measured indicators have no obvious changes. It has been placed under high temperature, high humidity, and light conditions for 10 days, except for a slight increase in related substances under light conditions. There was no significant change in other indicators. Accelerat...

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Abstract

The invention discloses an esomeprazole magnesium enteric-coated capsule and a preparation method thereof. The esomeprazole magnesium is prepared into enteric-coated pellets, and then the pellets are filled into gastric-coated capsules. The enteric-coated micropill of the present invention is composed of a blank pellet core, a drug-loaded layer, two isolation layers, an enteric-coated layer and a film coating layer. In order to ensure the stability of the drug, alkaline materials are added to the blank core; alkaline stabilizers and antioxidants are added to the drug-loaded layer; Conditioner. In order to ensure the dissolution effect, a surfactant is added to the enteric layer, and a film coating layer is coated on the outer layer to improve the stability of the product. Through the optimization of the formulation process of the pellets, the stability of the product is improved, the smoothness of the process is improved, the work efficiency is improved, the coating time is shortened, the consumption of manpower and material resources is reduced, and the production cost is reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical preparation with esomeprazole magnesium as an active ingredient, in particular to an esomeprazole magnesium enteric-coated capsule and a preparation method thereof. Background technique [0002] Esomeprazole is the left-handed isomer of omeprazole and the world's first single-isomer proton pump inhibitor (PPI) developed by AstraZeneca. Esomeprazole magnesium trihydrate, the molecular formula is C34H36N6O6S2Mg 3H2O, the chemical name is 5-methoxy-2-[(S)-[(4-methoxy-3,5-lutidine-2 -yl)methyl]sulfinyl]-benzimidazole magnesium salt (2:1) trihydrate, the structural formula is shown below. [0003] [0004] Gastric ulcer is a common and frequently-occurring disease. The drugs used to treat gastric ulcer mainly include proton pump inhibitors (PPIs), H2 receptor antagonists, antacids, gastric mucosal protective drugs, and anti-Helicobacter pylori. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/02A61K47/10A61K47/18A61K47/20A61K47/14A61K47/26A61P1/04
Inventor 卞建钢李成文王文波刘秀朋张庆霞高荣静彭杰
Owner DEZHOU DEYAO PHARMA
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